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临床试验/NCT06070233
NCT06070233招募中不适用

A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy

Ohio State University4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
22
试验地点
4
主要终点
Change in Modified Ashworth Scale

研究概览

简要总结

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
  • Age > 16 (if under 18, patients parents must sign consent).

排除标准

  • Inability to lie supine for simulation & treatment
  • Inability to visualize the target nerve on either CT or MRI imaging
  • Patients with confirmed pregnancy (all women of child-bearing age with intact uterus & ovaries will be required to undergo a pregnancy test prior to simulation)

结局指标

主要结局

Change in Modified Ashworth Scale

时间窗: 6 months post treatment

Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)

次要结局

  • Change in spasticity-related quality of life (SQoL-6D)(2 years post treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Palmer

Professor, Radiation Oncology

Ohio State University

研究点 (4)

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